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Cardiac Clinical Trials

Aortic Disease

Aortic Surgery Clinical Research Database

Primary Objective: The purpose of this study is to obtain patients clinical data and maintain it in an Aortic Surgery Clinical Research Database used for clinical studies. The study analyzes the risks, teatments, and outcomes of disorders of the thoracic and thoracoabdominal aorta. This research study is being done in order to improve patient treatment options and to better understand the treatment of pathologies of the aorta.

MRI for Post Aneurysm Aortic Remodeling

Thoracic aortic aneurysm (TAA) is a serious clinical condition in which the aorta (central blood vessel in the body) abnormally dilates due to intrinsic structural abnormalities in the aortic wall or tensile stress imposed by abnormal blood flow (resulting in vessel wall dilation). Patients with TAA are prone to aortic rupture (dissection), which can result in devastating clinical consequences including death. Surgical aortic grafting can reduce aortic size, and potentially mitigate dissection risk. However, the impact of different surgical techniques (i.e. extent of aortic grafting) on aortic hemodynamics is not known.

Primary Objective: This study will employ state of the art magnetic resonance imaging techniques - including phase velocity encoded flow imaging and vessel wall imaging - to assess aortic hemodynamics prior to and following surgical grafting. MRI will be performed prior to (within 6 months), and following (within 120 months) aortic graft surgery (exact timing of imaging to be determined by clinicians in accordance with clinical standard of care). The primary aim is to evaluate the effect of surgical replacement of portion of the aorta on the remaining native parts in terms of aortic flow, distensibility, size, and wall shear stress. Secondary aims include evaluation of the modification in aortic flow dynamics after replacement of part of the aorta and the prospective assessment of the growth rate of different portions of the aorta in different clinical scenario before and after surgical interventions. To address these aims, primary image analysis will be used to assess aortic flow and distensibility in native aortic segments distal to grafts, for which paired analysis on a per-patient basis will be used to assess physiological changes following surgical grafting. In addition, computational modeling (e.g. finite element analysis and fluid mechanics) will be also be used to assess novel parameters including aortic flow, shear stress, and distensibility.

Use of near infrared spectroscopy monitoring of the brain and the spinal collateral network during surgery on the thoracic and thoracoabdominal aorta

This is a prospective investigation aimed at evaluating the possible role of near infrared spectroscopy (NIRS) monitoring of the brain and the spinal collateral network in perioperative management of TAAA patients. NIRS technology is commonly used to non-invasively assess tissue perfusion in different clinical settings. In cardiac surgery, NIRS is routinely used to monitor cerebral oxygenation during operations on the aortic arch and has been shown to be extremely safe and effective. Recently NIRS has been described as a potential tool to evaluate the perfusion of the spinal cord during surgery of the thoracic aorta.

Primary Objective: In our study pre-, intra-, and postoperative data of 100 consecutive patients undergoing TAAA repair at WCMC will be recorded. The oximeter will be placed before the induction of anesthesia and will remain in place for 48 hours post operatively. In these patients spinal and brain NIRS will be routinely used during surgery and in the early postoperative period. NIRS data will be prospectively recorded and then correlated with the postoperative outcomes, hemodynamic parameters (Cardiac output/index, stroke volume, CVP, CPP, MVO2).

Evaluation of the Thoraflex Hybrid Device for use in the repair or Replacement of the Ascending Aorta, Aortic Arch, and Descending Aorta in an Open Surgical Procedure (Thoraflex Hybrid IDE study)

Primary Objective: To assess the effectiveness, safety and clinical outcomes of the Thoraflex™ Hybrid Device in the treatment of aortic disease affecting the aortic arch and the descending thoracic aorta, with or without involvement of ascending aorta.

Coronary Artery Disease

ROMA Trial

Primary Objective: The primary hypothesis of ROMA is that in patients undergoing primary isolated non-emergent coronary artery bypass surgery (CABG), the use of two or more arterial grafts compared to a single arterial graft is associated with a reduction in the composite outcome of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization. The secondary hypothesis is that in patients undergoing primary isolated non-emergent CABG, the use of two or more arterial grafts compared to a single arterial graft is associated with improved survival.

Prospective event-driven unblinded randomized multicenter trial of at least 4,300 subjects enrolled in at least 25 international centers. Patients will be randomized to a single arterial graft (SAG) or multiple arterial grafts (MAG). Patients will be randomized in a 1:1 fashion between the two groups. Permuted block randomization with random blocks stratified by the center and the type of second arterial graft will be used to provide treatment distribution in equal proportion.

Primary Objective: The purpose of this study is to evaluate the safety and performance of the CytoSorb® device to decrease the incidence or severity of acute kidney injury (AKI) as defined by Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guideline definition of acute kidney injury when used intra-operatively with cardio-pulmonary bypass (CPB) in subjects undergoing cardiac surgery.

Effect of open vs endoscopic radial artery harvesting for CABG on endothelial integrity, vascular innervation and NO Synthase expression

The best method of radial artery (RA) harvesting for coronary artery bypass surgery (CABG) is still a matter of debate. The open method (OM) was the first to be described and we think that it is the safest in terms of maintaining RA integrity. On the other hand, the closed endoscopic method (EM) is experiencing exponential rate of adoption due to its superior cosmetic results and greater acceptance by the patients. However, the less controlled method of endoscopic harvest may cause more damage to the RA endothelium.

Primary Objective: This is a prospective investigation aimed at evaluating the effect of two different techniques of RA harvesting for CABG on vascular wall integrity. Pre-, intra-, and postoperative data of 30 consecutive patients undergoing primary isolated elective CABG with the RA at WCMC and NYPH Methodist will be recorded. Most importantly, the last 10-20 mm of the RA (that usually are not used for CABG and are discarded as medical waste) will be submitted to pathology for immuno-histochemical evaluation of the integrity of the endothelium, the tunica media and the innervation. We will also be collecting discarded specimens (medical waste) of saphenous vein and/or internal thoracic artery as a comparison to the radial artery.

Atrial Fibrillation

Prevention of Atrial Fibrillation after Cardiac Surgery (PALACS). A prospective randomized clinical trial aimed at evaluating the efficacy of a new method for the prevention of postoperative atrial fibrillation: Posterior left pericardiotomy for the prevention of postoperative atrial fibrillation after cardiac surgery.

Primary Objective: To determine the incidence of Post-Operative Atrial Fibrillation (POAF) after cardiac surgery when posterior pericardiotomy is performed.

Secondary Objectives: To determine the incidence of post-operative pericardial or pleural effusions after cardiac surgery when posterior pericardiotomy is performed.

Primary Objective: The purpose of this trial is to establish the safety and efficacy of the Edwards SAPIEN 3 THV device in patients with severe, calcific, aortic stenosis who are at low operative risk for SAVR.

Secondary Objectives: CT Sub-Study: The purpose of the study is to investigate the prevalence of the imaging abnormality.

Primary Objective: The PORTICO clinical trial is designed to evaluate the safety and effectiveness of the SJM Portico Transcatheter Heart Valve and Delivery Systems (Portico) via transfemoral and alternative delivery methods.

Secondary Objectives: Objective for Version K: Enrollment of randomized subjects in the Portico IDE study is anticipated to be completed in September/October 2017. Conduct of the CAP will follow the pivotal IDE study

Validation of a personal fitness tracker as a predictor and motivational tool in cardiac surgery

Primary Objective: The use of wearable personal fitness monitors (WPFMs) in risk assessment and as recuperation aids in minimally invasive cardiac surgery (e.g., transcatheter aortic valve replacement (TAVR)) are novel concepts and largely unreported in the literature. Hence, this study may potentially help to create new paradigms for cardiac surgery patient selection and postoperative recovery.

THE PARTNER II Placement of AoRTic TraNscathetER Valve Trial

Primary Objective: This clinical trial is for men and women who are diagnosed with severe aortic stenosis and are at intermediate-risk for traditional open-heart surgery for aortic valve replacement.

The purpose of the study is to assess the safety and effectiveness of the SAPIEN XT and SAPIEN 3 transcatheter heart valves. Unlike traditional replacement aortic valves, they are implanted with a catheter procedure to eliminate the need for surgery. These devices are approved by FDA for patients who are at high-risk for traditional open-heart surgery.

Study subjects will be followed up for 5 years after placement of the stent.

Primary Objective: To demonstrate the safety and effectiveness of the Perceval S heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.

This investigation is a prospective, non-randomized, multi-center trial of the PERCEVAL valve implanted in patients requiring aortic valve replacement. The study will be conducted in a maximum of 25 centers in the United States. Patients will be evaluated at each of the following time intervals:preoperative, at implant, in the early postoperative period, in the late postoperative period (between 3 and 6 months postoperatively), at 1 year (between 11 and 13 months postoperatively), and annually until study completion. The duration of the study is anticipated to be 5 years.

Primary Objective: The objective of this trial is to confirm that the modifications to tissue processing, valve sterilization and packaging do not raise any new questions of safety and effectiveness in subjects who require replacement of their native or prosthetic aortic or mitral valve.

Multicenter, prospective, single arm trial - Up to seven hundred (700) aortic valve replacement (AVR) subjects and up to one hundred seventy-five (175) mitral valve replacement (MVR) subjects at up to forty (40) clinical sites will be enrolled. The trial will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valve. Patients will be followed and assessed after implant for up to 5 years.